Egoropal

GIF decision: Withdrawal from market, Marketing prohibition

What does this decision mean?

• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
• Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

Serious deficiencies were detected in aseptic manufacturing, creating a threat to product quality. A risk to patients' health or life cannot be excluded, particularly due to the parenteral injectable form of the medicine. Potential effects: infection, severe injection-related complications, lack of therapeutic efficacy.

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Risk Level

Critical

Manufacturer

Egis Pharmaceuticals PLC z siedzibą w Budapeszcie, Węgry

Batch Number

4400718, 4500766, 4501274, 4400293, 4400851, 4500598, 4500832, 4500892, 4501060, 4501376

Notice Date

08.01.2026

What to do if you have this product?

A recall means the product may be unsafe. Here is what to do if you have it at home.

1

Do not eat or use the product

Stop using or consuming it immediately and keep it out of reach of children.
2

Check the batch number and expiry date

Compare the batch/lot number and the best-before or expiry date with the details in the alert — sometimes only specific batches are affected.
3

Return it to the shop

You can take the product back to the shop where you bought it. For a safety recall a refund is due even without a receipt.
4

Get help and report it

If you feel unwell after using the product, contact a doctor. You can also report the case to the relevant authority — GIS, GIF or UOKiK.

General guidance for recalled products in Poland. Always follow the specific instructions in the official alert and from the manufacturer or retailer.

Important Information

What You Should Know

Recommendations

Do not use Egoropal (Paliperidone) 75 mg and 150 mg products from the listed batches. If a patient possesses a pack from one of these batches or has received such a batch during treatment, they should...

Actions Taken

The Chief Pharmaceutical Inspector withdrew the specified batches of Egoropal 75 mg and 150 mg from the market throughout the country. A ban on placing these batches on the market was issued. The deci...

Need Help?

If you feel unwell after consuming this product, contact your doctor or call the poison control center.

Egoropal

What to do if you have this product?

What You Should Know

Recommendations

Actions Taken

Need Help?

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